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65 patients were included after 2 years instead of 140
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A recent study has demonstrated that in low respiratory infections, a strategy using prescription of antibiotics based on the pro-calcitonin level allows decreasing recourse to antibiotics by 47% without prognostic modification.
The aim is to evaluate the impact on antibiotics consumption of an algorithm using procalcitonin level in patients exhibiting severe sepsis symptomatology but without clearly identified hosted germs or infectious centre.
This multicenter study is a randomized prospective open study involving 9 ICU departments in France, comparing two strategies on antibiotherapy treatment period one based on procalcitonin level(experimental group) the other on physician's appreciation(control group)
140 adult patients should be included with a severe sepsis symptomatology, whose infectious etiology has not been proven. The main non-inclusion criterium is: the presence of a pathogen agent or infectious centre clearly identified.
The primary outcome is the rate of patients undergoing antibiotic treatment at D5.
Secondary outcomes: duration of the antibiotic treatment, mortality rate and duration in stay in intensive care ward and evolution of the SOFA score between D0, D3 and D5.
Duration of patient enrollment is 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procalcitonin level | Other | duration of the antibiotic treatment guided by procalcitonin level |
|
| physician's appreciation | No Intervention | duration of the antibiotic treatment based on physician's appreciation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procalcitonin level | Other | The duration of antibiotic treatment is based on PCT level:
|
| Measure | Description | Time Frame |
|---|---|---|
| rate of patients undergoing antibiotic treatment at D5. | at D5 |
| Measure | Description | Time Frame |
|---|---|---|
| evolution of the SOFA score between D0, D3 and D5. | D30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Djillali Annane, Professor | Raymond Poincaré hospital Garches-France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICU in J.Minjoz hospital | Besançon | 25030 | France | |||
| ICU in Avicenne hospital |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077740 | Procalcitonin |
| ID | Term |
|---|---|
| D002116 | Calcitonin |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Bobigny |
| 93009 |
| France |
| ICU in Ambroise Paré hospital | Boulogne | 92100 | France |
| ICU in Raymond Poincaré hospital | Garches | 92380 | France |
| ICU in André Boulloche hospital | Montbéliard | 25200 | France |
| ICU in Centre hospitalier général | Mulhouse Belfort | 90000 | France |
| ICU in St Etienne hospital | Saint-Etienne | 42055 | France |
| ICU in Purpan hospital | Toulouse | 31059 | France |
| ICU in Rangueil hospital | Toulouse | 31059 | France |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D011506 | Proteins |